SCHENECTADY — The Capital Region’s only plasma collection center began hosting donors last month and sent out its first frozen shipment on April 24. As much as a year from now, somewhere in the world, a highly refined derivative of that plasma will be ready to be injected or infused back into someone else as therapy for a serious medical condition.
CSL Plasma’s new site on upper State Street brings together a gleaming array of technology to perform the first step in turning human blood into medicine. Plasma, the pale gold-colored portion of blood, contains proteins used to create therapeautics to treat immune disorders, hemophilia and other conditions. The proteins cannot be replicated in a laboratory.
Florida-based CSL Plasma is growing rapidly, opening 26 centers in 2018 at an average cost of $1.3 million each. The Schenectady site was one of the first completed in a continued wave of expansion in 2019, though its opening was delayed from January to April as a medical director holding all of the required New York state certifications was recruited.
The workforce is 22, all but one of them full-time. That is expected to expand to 30 to 35 when the facility hits its stride. Current donation volume wouldn’t support that level of staffing, but activity at new CSL collection centers typically grows rapidly. The Syracuse site is collecting 900 donations a week now, one year after opening. The Schenectady site’s goal is 900 to 1,000 a week.
Melissa Moore, manager of the State Street center, explained how the facility works.
The team of registered nurses, lab technologists, lab technicians, lab supervisors, processing technicians, phlebotomists, managers, quality-control monitors and repair technicians runs a facility with 18 donor stations and capacity to expand to 48.
Donors must be 18 to 65 years old and weigh at least 110 pounds. New donors are given an extensive medical history review and health assessment before their first donation. Each time they return, they are checked against two national donor databases to make sure they aren’t donating more than twice a week, 104 times a year.
The donor reclines for the procedure. Whole blood flows from an arm vein into a centrifuge that separates out the plasma at 7,000 rpm. The red blood cells are pumped back into the donor, along with saline and an anti-coagulent. Plasma — 690 to 880 milliliters of it, depending on the donor’s size — flows into a bottle.
The donor is paid $20 to $40, depending on the volume of plasma collected. (New donors get $50 for each of their first five donations.)
The bottle of plasma is chilled to minus-32 degrees fahrenheit. Small samples are extracted for testing at a CSL Plasma facility in Knoxville, Tennessee, during a waiting period. If no disease or other red flags are found, the plasma is shipped out to a central facility in Indiana where it will undergo seven to 12 months of processing.
The process is similar to donating whole blood, with a couple of critical differences: More than two pints of whole blood is extracted from plasma donors vs. just one pint from blood donors, and about a pint of red blood cells is returned to the plasma donor vs. no return for the blood donor.
Red blood cells, about 45 percent of blood volume, perform the critical role of carrying oxygen through the body. It takes several weeks for the body to regenerate them after they are drawn. Blood donation protocol is no more than one pint per 56 days, while FDA regulations allow up to two plasma donations in a seven-day period.
There are simple guidelines for the plasma donor: Eat a good meal and drink a lot of water before and after the donation; lay off caffeine and tobacco if possible.
The process takes 45 to 90 minutes, typically.
“We’ve seen it done as fast as 25 minutes,” Moore said. “If the person is very well-hydrated and has a great diet it can be very fast. If they’re well-hydrated their veins are a bit engorged.”
CSL Plasma has one of the largest and most sophisticated collection networks in the large and growing plasma biotherapeautics industry. It now operates more than 200 donor sites, plus logistics and testing facilities. It and parent company CSL Behring form a vertically integrated pathway from a donor’s veins to the vials of medicine for patients.
CSL Behring has a workforce of 22,000 and reported sales of $6.7 billion in 2017-2018 sales, more than half of that the immunoglobulins that help people with immune deficiencies.
The Plasma Protein Therapeutics Association said the amount of plasma donated and number of plasma donation centers more than doubled in the United States from 2007 to 2017, climbing from 349 to 750 sites and from 15 million to 45 million donations.
The domestic plasma industry also has become a major exporter.
“The U.S. is by far the leading provider of source plasma worldwide,” said Matt Gulick of the PPTA.
Possible explanations for this include some other countries not allowing companies to pay for plasma donations, or not allowing donations as frequently as the United States does.
Gulick said donation statistics vary widely from country to country.
As noted, whole blood and plasma donations are essentially the same process, aside from plasma donors getting their red blood cells back. But a plasma donor gets money (or a debit card if they donate at CSL Plasma) while a whole blood donor may get only a cookie and a cup of juice.
The World Health Organization has long been trying to steer the medical community away from paid donations. It is not illegal to pay for a whole blood donation in the United States, but any whole blood from a paid donor must be labeled as such, and that apparently carries a stigma that effectively precludes it from common use.
Blood drive giveaway incentives that carry no ready cash value, such as a raffle ticket, T-shirt or plush toy, are not considered monetary compensation.
The American Red Cross and the AABB, formerly known as the American Association of Blood Banks, both declined comment for this story when asked if there was any competition for donors; the Red Cross regularly finds itself appealing for whole blood donors because of shortages.
There exists an odd divide between the two types of donation: Giving whole blood is an act of altruism and unpaid even though it is classified as having a greater physical impact on the donor, while giving plasma is a source of income.
A CSL Plasma spokesman said the company chooses the location for its donation centers based on population density, zoning permission and accessibility. U.S. Census data also show that all but one of its centers in New York state are located in ZIP codes where the median household income is lower than the surrounding county. In other words, amid neighborhoods whose residents might have a greater need for extra income.
CSL Plasma’s new Schenectady facility, for example, sits next to a discount grocery store, on a bus line, in a ZIP code with a median household income that is 80% of the median in Schenectady County.
Its Syracuse and Buffalo sites are in ZIP codes where the median is 70% and 50% of the county median, respectively.
Assuming total travel and on-site time of 90 minutes and payment of $20 to $40 per donation, a plasma donor would earn $13.33 to $26.66 per hour, tax-free — a good to extremely good part-time wage.
Whatever the differences in the donation protocol, donated whole blood and plasma both save lives or make them better by addressing critical medical needs. A single immune-compromised patient will need medicine made from 130 or more units of plasma per year, while a year’s treatment of a single hemophilia case requires meds distilled from more than 1,200 plasma donations.
CSL Plasma is trying to raise awareness of this through its Adopt-A-Patient program, which puts recipients of plasma-derived therapy in the collection sites, where staff and donors alike can meet them and learn about the impact donated plasma has. They are unpaid in this role.
New in this role at the Schenectady center is Rachel Rhodes, 22, of Saratoga Springs, who has had common variable immune deficiency since birth.
“I used to have infections that would last for months and keep getting worse,” she said. “Antibiotics didn’t help, and I had to miss a lot of school because I was sick all the time.”
She began immunoglobulin replacement therapy at age 15, and has since had a significant improvement in quality of life. She works in retail sales now, a job that might otherwise place her in proximity to too many germs.
“I want to talk to donors and put a face to what they’re donating to,” Rhodes said. “People donate but they don’t know what it’s for.”
Moore, the manager, said the Immune Deficiency Foundation connected Rhodes to the Schenectady facility, which she otherwise has no connection to — she is unable to be a donor herself, due to her condition.
“People like Rachel are why we do what we do,” Moore said.